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Job Details

Clinical Quality Assurance Lead, Germany or Switzerland

Company: Barrington James Clinical
Location:
Reference: JG/GCPQALEAD
Closing Date: 12 Mar 18
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

My client is a global Biopharmaceutical company. Working in ground breaking products for their patients. They are looking for a  proven line manager to lead their GCP Auditing department. The role itself will include around 3 or 4 Audits a year and Audit observation or line reports. The role involves around 20% travel and you would need to be a proven GCP Auditor with Line management skills or line management capabilities.

Requirements:

My client is a global Biopharmaceutical company. Working in ground breaking products for their patients. They are looking for a  proven line manager to lead their GCP Auditing department.

The role itself will include around 3 or 4 Audits a year and Audit observation or line reports.

The role involves around 20% travel and you would need to be a proven GCP Auditor with Line management skills or line management capabilities.

 

Responsibilities

 

Line management of direct reports, i.e. perform mid-year and annual reviews, manage performance, develop and manage Individual Development Plans, coach/train/ mentor, etc.

Drive and oversee the execution of the Global CQA Audit Program and forecasting audit demand in the region, supporting the Head of CQA in managing the Global CQA Audit Program and Quality System. Support of Global CQA audits/ activities, as needed.

Management / oversight of the regional CQA budget.

Lead assigned CQA compliance areas.

Liaise with Global Counterparts to manage Global Audit Resourcing, including management of CQA contractors, and / or CROs conducting activities on behalf of Global CQA.

Supervise, plan and conduct, and / or assist audits in relation to the Global CQA Audit Program in order to assess the accuracy and quality of scientific data and / or ensure compliance with relevant guidelines, legal requirements and GCPs (and / or other relevant GXPs- GMP, GLP, etc.), including an adequate audit follow-up / CAPA management.

 

 

Experience Required

Minimum: University degree in Scientific Discipline/ Life Sciences or related disciplines.

Minimum of 10 years of pharmaceutical industry experience, 5-7 years experience in Clinical Quality Assurance with other relevant GXP experience, preferred. Team management experiences.

Very good knowledge of Good Clinical and Good Laboratory Practices and Quality Management System especially on audit procedures and reporting and CAPA management .

Good expertise in international and national regulations and guidelines with the ability to understand and interpret applicable regulations.

With a thorough understanding of the drug development process.

 

To find out more call James Greenfield on +49 69 274 015 840 or email jgreenfield@barringtonjames.com

Apply for this job: Clinical Quality Assurance Lead, Germany or Switzerland

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
RH6 7AF
England
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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